Lyumjev ® (insulin lispro)

För fullständig produktresumé för Lyumjev se FASS.

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Lyumjev® ▼ (insulin lispro): Fas 3 Pumpkompatibilitet och säkerhetsdata

I PRONTO-Pump-studien fanns det ingen signifikant skillnad i felfrekvensen av infusionsset mellan behandlingsgrupperna Lyumjev och IL-100.

Compatibility and Safety Data in Phase 3 Pump Study

The rate of infusion set failures met the primary endpoint and was similar for URLi (LY900014) and IL-100. Five events of infusion set failures in 5 patients met the primary endpoint, all due to pump occlusion alarm. The rate of infusion set failure was

  • 0.05 events/patient/30 days with IL-100, and

  • 0.04 events/patient/30 days with URLi (LY900014).1

The infusion set failures occurred on day 1 of infusion set wear in the URLi (LY900014) treatment group and on day 2 of infusion set wear in the IL-100 treatment group.1,2

PRONTO-Pump was a phase 3, prospective, randomized, double-blind, crossover, active-controlled, outpatient, multinational study that compared URLi (LY900014) with IL-100, both administered via CSII with Dexcom G5, in adults with T1DM.2

The phase 3 pump study was designed to compare URLi (LY900014) with IL-100 with respect to the rate of infusion set failures in events/patient/30 days that led to

  • premature infusion set changes due to a pump occlusion alarm, or

  • unexplained hyperglycemia with BG >13.9 mmol/L (>250 mg/dL) that did not decrease within 1 hour following a correction bolus delivered via pump.2

Unexplained hyperglycemia was defined as a high BG concentration that could not be explained by

  • a missed prior bolus

  • dietary indiscretion

  • rebound or treatment of hypoglycemia

  • a pump failure

  • an empty pump reservoir

  • an infusion set complication such as kinked, came out, or leaking, or

  • an infusion site complication such as pain or redness.1

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Bode BW, Liu R, Hardy TA, Ignaut DA. Compatibility and safety of ultra rapid lispro (URLi) with continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes: PRONTO-pump study [abstract 790]. Diabetologia. 2019;62(suppl 1):S383. http://dx.doi.org/10.1007/s00125-019-4946-6

Glossary

BG = blood glucose

CSII = continuous subcutaneous insulin infusion

Dexcom G5 = Dexcom G5® Mobile Continuous Glucose Monitoring System

IL-100 = Humalog® (insulin lispro injection) 100 units/mL

PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes

T1DM = type 1 diabetes mellitus

URLi = ultra rapid lispro

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn October 25, 2019


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